UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Acronym	DREX Study
Scientific Title	Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Scientific Title:Acronym	DREX Study
Region	Japan

Condition
Condition	diabetic retinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Development of a new system for evaluating visual function in diabetic retinopathy using EvokeDx
Basic objectives2	Others
Basic objectives -Others	To evaluate the relationship between the grade of diabetic retinopathy and visual function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual function measured by EvokeDx
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy adults and Diabetic patients who have best-corrected visual acuity better than 0.7 in decimal.
Key exclusion criteria	Patients with diabetic macular edema, galucoma, and who had been treated diabetic retinopathy within 12 weeks. If the researchers found the person not suitable for the study, the person will be excluded from the study.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Ozawa
Organization	St Luke's International Hospital
Division name	Department of Ophthalmology
Zip code	1048560
Address	9-1 Akashicho Chuoku Tokyo Japan
TEL	03-3451-5151
Email	ozaway@luke.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Department of Ophthalmology Last name Ozawa
Organization	St Luke's International Hospital
Division name	Department of Ophthalmology
Zip code	1048560
Address	9-1 Akashicho Chuoku Tokyo Japan
TEL	03-3451-5151
Homepage URL
Email	ozaway@luke.ac.jp

Sponsor
Institute	St Luke's International University
Institute
Department

Funding Source
Organization	SENJU PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of St Luke's International Hospital
Address	9-1 Akashicho Chuoku Tokyo Japan
Tel	03-3451-5151
Email	kenkyukikaku@luke.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 05 Month 19 Day
Date of IRB	2020 Year 07 Month 02 Day
Anticipated trial start date	2020 Year 07 Month 02 Day
Last follow-up date	2023 Year 08 Month 31 Day
Date of closure to data entry	2023 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 12 Month 31 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information	NONE

Management information
Registered date	2020 Year 05 Month 19 Day
Last modified on	2021 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046156